Patient Status Engine (PSE): EARLY FEASIBILITY AND USABILITY STUDY

NCT ID: NCT03480204

Last Updated: 2019-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-19

Study Completion Date

2018-12-23

Brief Summary

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This study evaluates the feasibility and usability of a wearable patch as a cardiac monitor for non-ICU hospitalized patients.

Detailed Description

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This study evaluates the feasibility and usability of a wearable patch cardiac monitor, gateway and server concomitant with standard-of-care cardiac telemetry monitoring for non-ICU hospitalized patients on a selected nursing ward at the Cleveland Clinic Heart and Vascular Institute. All patients will receive routine clinical care on the basis of the traditional telemetry monitoring using the usual processes. The patch monitor data will not be reviewed in real-time, and only analyzed post hoc for agreement with the standard-of-care.

Conditions

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Cardiac Arrhythmia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* \>= 18 years old and able to provide informed consent
* Standard indication for cardiac telemetry monitoring (institutional standardized criteria) with valid electronic order

Exclusion Criteria

* Cardiac implantable device (pacemaker or ICD)
* Contact precautions or isolation
* Telemetry discontinuation planned within 12 hours (i.e. anticipated discharge)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Isansys Lifecare LTD

UNKNOWN

Sponsor Role collaborator

The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

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Dan Cantillon

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daniel J Cantillon, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

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Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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17-1656

Identifier Type: -

Identifier Source: org_study_id

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